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NRI Awarded with the Flagship Site Award from Medpace

It is an honor and privilege to announce NRI’s collaboration and selection into Medpace’s Site Flagship program. This Site Flagship program is a special award based on NRI’s high quality data and ability to meet or exceed study timelines on a consistent basis. We look forward to a successful partnership with Medpace.

The sensor-enabled medication, developed by Proteus Digital Health, is a combination of an ingestible sensor about the size of a grain of sand coencapsulated with a medication at a compounding pharmacy, said Juan Pablo Frias, MD, FACE, president and CEO of the National Research Institute in Los Angeles, speaking during an oral presentation session. The patient wears a sensor-enabled patch, described by Frias as the size of a standard bandage, that senses when the medication is taken and sends a signal to an application on a mobile device. The technology has been cleared as an FDA device, he said, though he could not offer information on its cost.

“The patch not only senses when the medication is taken, but also serves as a pedometer, so it gives an indication of patient activity as well as patient rest, and provides some very interesting and useful reports to the patient when they’ve missed medications as well as number of steps and the rest that they’re getting,” Frias said.

The data are sent to the patient and, when enabled, are sent to a cloud platform, allowing health care providers to view the patient’s Web portal and pull customized reports.

“We could follow a panel of patients that were taking these sensor-enabled medications, and also, when an individual patient comes to clinic … I would have a customized report that I could review with the patient to talk about any issues with adherence or not meeting their lifestyle goals,” Frias said.

Within the digital health arms, a mean of 84% adhered to sensor-enabled statin therapy, Frias said. Adherence counseling and patient education were also higher in the digital health vs. control group, according to case reports, Frias said.

Over 90% of 31 survey respondents agreed the digital platform was easy to learn and use, helped them with taking medicines more regularly, and improved conversations with their providers, Frias said.

“From my personal perspective … [the study] really was unique, and the patients certainly enjoyed doing it,” Frias said. “It really did involve [patients] more in their care, and in our patients we did see improvements in these [clinical] outcomes, more than likely due to enhancement in adherence, not only in medication taking, but also in their physical activity.”

Study co-author Naunihal Virdi, MD, FACP, head of medical science at Proteus Digital Health, said the tiny sensor is made of magnesium and copper, with a “silicon wafer” in between.

“The way it functions is almost like a potato battery,” Virdi said, responding to a question about the sensor’s safety. “When you swallow it, it gets in contact with fluid, and little voltage forms between the two metals. That voltage powers the chip that sends the signal.”

The device was found to be safe in hundreds of patients through 20,000 ingestions, with only transient gastrointestinal side effects or skin irritations at the patch site reported, Virdi said. – by Regina Schaffer

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